Questionnaires designed to evaluate health outcomes are
currently used primarily in Phase III clinical trials for
chronic diseases where the intended effect of treatment is
to slow the progress of the patient's disease or condition.
For use in multinational clinical trials, the content must
be: relevant globally, simple to
complete and have the performance characteristics that
support their intended use. Additionally, the results
should be understandable and meaningful for the medical
community, patients and the regulatory agencies.
Requirements
for PROs in Global Clinical Trials
-
Content that is
globally relevant
-
Simple for patients to answer
-
Adequate performance
characteristics for their use
-
Results that are easy to understand and
meaningful
Key Points in Choosing a PRO Questionnaire
-
What is the intended
use of the questionnaire
-
what magnitude of change is expected
-
What are the characteristics of
the individuals
who will complete the questionnaire
-
Is there an existing
questionnaire that is adequate
How to Select Good Questions
Outcomes scientists often use the
'battery approach' where scales
are selected from
several PRO
questionnaires and combined to
form a new questionnaire.
This approach
is appealing, but
has many challenges. Health
Outcomes Group has developed the
Merit Method for selecting good
questions. This method can
be used to shorten questionnaires
and improve the overall
efficiency without loss of
valuable information.
Benefits of the Merit Method
An objective method
to select good questions
Can achieve significant
efficency without sacrificing performance
characteristics
Improves quality of
the data
Reduces costs and the patient
burden